effect of evolocumab added to moderate-intensity statin therapy on ldl-c lowering and cardiovascular adverse events in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome; Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor

Summary: the study is an open-label, multicenter, and randomized study(five hospitals).the purpose of this study is to assess the differences in the effects of the evolocumab added to moderate-intensity statin therapy and the moderate-intensity statin only therapy on the regulation of ldl-c levels in patients with acute phase acute coronary syndrome after four weeks of treatment. the primary outcome is the percentage change in ldl-c in weeks 4 and week 12 after treatment. the secondary outcome is the occurrence of mace after 12 weeks and 1 year of treatment.


Eligibility criteria:
inclusion criteria: * recent hospitalization for acute coronary syndrome: complies with the diagnostic criteria for acute coronary syndrome (non-st-segment elevation myocardial infarction, acute st-segment elevation myocardial infarction, and unstable angina within 72 hours of onset) * ldl-c level (meet one of the following conditions): 1. prior to the study, patients who received intensive statins for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with ldl-c levels ≥70 mg/dl (≥1.8 mmol/l) or non-hdl-c ≥100 mg /dl (≥2.6mmol/l) are included in the study; 2. prior to the study, patients who received moderate-intensity statin therapy for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with ldl-c levels ≥90 mg/dl (≥2.3 mmol/l) or non-hdl-c≥ 120mg/dl (≥3.1mmol/l) are included in the study; 3. prior to the study, patients who do not receive statin therapy or who do not continue to receive statin with ldl-c ≥ 125 mg/dl (≥ 3.2 mmol/l) or non-hdl-c ≥ 155 mg/dl (≥ 4.0 mmol/l). * being able to understand research requirements and sign informed consent exclusion criteria: * unstable clinical status (hemodynamics or ecg instability) * uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia and atrial fibrillation with rapid ventricular reaction that the drug cannot control within three months prior to screening * severe renal insufficiency, defined as estimated glomerular filtration rate\<30ml/min/1.73m2 * active liver disease or liver dysfunction, whether it is on the patient's medical record or defined as an increase in alanine aminotransferase or aspartate aminotransferase more than 3 times above the upper limit of normal * records on statin or rosuvastatin (any dose) intolerance or other statin intolerance * known allergies to contrast agents, heparin, aspirin, ticagrelor or clopidogrel * known allergies to the supplements required for the use of the drug * patients who have been treated with evolocumab or other pcsk9 inhibitors * received cholesterol ester transfer protein inhibitors treatment 12 months prior to screening * received systemic steroid or cyclosporine treatment in the past 3 months * known infections, hemorrhages, metabolic or endocrine disorders as determined by the researchers * patients who have been included in other studies * patients with active malignant tumor in need of treatment * women with fertility (age \<50 years, menstruation in the past 12 months), did not receive tubal ligation, oophorectomy or hysterectomy

Keywords: acute coronary syndrome proprotein convertase subtilisin/kexin type 9 inhibitor lipid-lowering drug major cardiovascular adverse events